Drug Development
Drug Development Services
We are specialised in development of complex molecules, including new chemical entities, value-added medicines, and both generic and generic plus products. Our offerings include out-licensing, supply chain solutions, specialised analysis, custom developments, and formulation services. We have a refined process for project management, ensuring timely delivery within budgetary constraints.
Adopting a multidisciplinary approach, our pharmaceutical formulation and process development seamlessly incorporates advanced analytical techniques, manufacturing technologies, and principles of Quality by Design (QbD) and Quality Risk Management (QRM) at every stage of development.
The HPAPI Laboratory is equipped to safely manage High Potency Active Pharmaceutical Ingredients (HPAPI) with an Occupational Exposure Limit (OEL) not lower than 0.5 μg/m³.
Our state-of-the-art laboratories offer a wide range of analytical services to support our clients specific needs, under strict quality procedures that meet GMP requirements and follow ICH Guidelines.
Clinical development for NCEs (New Chemical Entities), value-based medicines, and generic and generic plus medicines is provided by us. Assisting our clients in navigating the complex landscape of clinical development by proposing the optimal plan for success is our role.
We orchestrate regulatory activities to steer towards achieving a successfully approved dossier. Our team of experts possesses a comprehensive understanding of the latest international regulatory shifts and commits itself to providing exceptional support in both submission processes and documentation management.
Read more ->Our Approach
We offer tailor-made services that cover a wide range of industry needs. From out-licensing and supply to one-off analysis, custom developments, and advanced formulation services, we can provide a full range of services. We excel in project management for drug development. Our streamlined process ensures smooth progress from start to finish, keeping each project on schedule and within budget. With experienced project managers and proper communication, we effectively tackle complexities, delivering successful outcomes. Whether you’re looking for a co-development model where we work together to bring a product to market, prefer licensing and royalty agreements to leverage our expertise and resources, or seek a straightforward fee-for-service arrangement for specific activities, we have the flexibility to accommodate your requirements.
Quality by Design
An integral part of every development initiative we embark on. By integrating QbD across the entire commercial manufacturing spectrum, we achieve the consistent development of pharmaceutical products that meet the highest standards of quality. This steadfast commitment to QbD at every stage ensures our products not only comply with regulatory expectations but also exceed industry benchmarks for excellence.
U.S. FDA- Compliant Drug Development
Since 2022, we have been in compliance with U.S. FDA regulations for drug development services. Beyond aligning our quality system and standard operating procedures with U.S. requirements, our skilled team is adept at managing the development of new product applications, including ANDA and 505(b)(2), specifically for the U.S. market. We fully support the development and validation of analytical methods according to U.S. regulatory requirements and formulation development based on the experimental QbD principles.
Our Services
We specialise in New Chemical Entities (NCE), Value Added Medicines (VAMs) and generic product developments. We have a highly experienced team of more than 60 scientists that have worked on numerous innovative products.
Formulation Development
- API characterization
- Preformulation
- Formulation development
- Analytical method development
- Process development
- Technology transfer
- IP Search (Intellectual property)
Analytical Services
- Method development and validation
- Chemical compatibility
- Forced degradation
- Dissolution (USP I, II and III)
- Chemical analysis of APIs
- Finished product controls
- ICH stability, photostability and in-use stability
Scientific and Clinical Development
- Clinical strategy
- Study design and sample size calculation
- BCS Biowaivers
- Dissolution data analysis
- IVIVC
- Clinical trial project management
- Nonclinical and clinical overviews
- Scientific advice meetings
Regulatory Services
- Regulatory and registration strategy
- Scientific report writing
- Compilation and publishing of data in eCTD format
- Liaising with regulatory authorities
- Registration services and support
- Risk assessment reports
Meet our experts
Highly skilled and well-trained scientists focused on development.
Aggelos Karatzas
Site Head, Athens
John Kytariolos
Head of Clinical & Scientific Affairs, Athens
Konstantinos Apostolou
R&D Senior Manager, Athens
Argyro Stappa
Head of R&D, Athens
Amalia Stroumpou
Head of GMP Analytical/QP, Athens
Lenia Papadimou
Head of Regulatory Affairs, Athens
Christina Koulouri
Head of Project Management & Supply Chain, Athens